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`CAREER SUMMARY
`(1983 – 1993)
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`(1993 – 2000)
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`(2000 – 2004)
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`(2004 – Present)
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`CURRICULUM VITAE
`
` Joseph M.D. Fortunak
`
`United States citizen
`
`5 Countryside Court
`
`Silver Spring, MD 20905 USA
`
`+1 (301) 928 7568 (Mobile)
`
`jfortunak@howard.edu
`
`jfortunak@comcast.net (Preferred)
`
`Purdue University
`BSc, Chemistry
`With highest distinction
`University of Wisconsin-Madison
`PhD, Organic Chemistry (1981)
`With highest distinction
`Cambridge University, United Kingdom
`Postdoctoral Fellow/ Research Assistant
`Professor (1981-83)
`
`SmithKlineBeecham (GlaxoSmithKline)
`Pharmaceutical Corp. Associate Senior
`Research Investigator, Senior Research
`Investigator, Assistant Director
`DuPont Pharmaceutical Company
`Associate Director, Director,
`Senior Director, Executive Director
`Abbott Labs; Pharmaceutical Company
`Head of Global Chemical Development
`Howard University
`Professor of Chemistry and
`Pharmaceutical Sciences
`
`
`
`1 
`
`DRL Ex. 1018, p. 001
`
`

`

` 
`
`
`STATEMENT OF PURPOSE
`
`I am a Professor at Howard University, a Research Tier-1, historically black university
`(HBCU) in Washington, DC.
`
`Our research work in COVID-19 has resulted in a (to-date unpublished) new, green
`synthesis of the drug hydroxychloroquine that reduces the number of chemical steps from 5
`to 3 and improves the overall yield. We have also published on the reasonable generic
`manufacturing costs at commercial scale of drugs for treating COVID-19 (Journal of Virus
`Eradication, 2020), that has been widely cited in the news media (Le Monde, Reuters,
`Bloomberg News, San Jose Mercury News, The Guardian; several TV and Radio
`interviews).
`
`Prior to joining Howard University, I worked for 21 years in the originator pharmaceutical
`industry as a scientist and manager. I have managed groups as large as 500 people and
`budgets of $150MM/year. The drugs that I have brought through development to the market
`have sold approximately USD$200Billion.
`
` I
`
` joined Howard University in 2004 as an Associate Professor in the Departments of
`Chemistry and Pharmaceutical Sciences. My research group of PhD/PharmD/MSc and
`undergraduate students creates new science to decrease the cost and increase global
`access to medicines of assured quality. We teach drug discovery, development, regulation
`and quality assurance to African and Asian professionals to promote local pharmaceutical
`manufacturing in several countries. Our new chemistry and technologies have contributed to
`greatly reduced prices of several drugs for HIV/AIDS, malaria, and HCV for over 20 million
`people. We also create new science to lower the dose and improve the safety of essential
`medicines to promote global access, particularly by discovering novel cocrystals of critical
`drugs with pharmacokinetic enhancers (PKEs).
`
`In 2005 I helped found the Drug Access Technical Team (DAT) of the William J. Clinton
`Health Access Initiative (CHAI). I have contributed to successes in the following areas to
`increase access to medicines for HIV/AIDS, malaria, and TB:
`
`2 
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` 
`
`DRL Ex. 1018, p. 002
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`

`

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`
`1. Suppliers meeting international standards of quality for generic production
`2. Negotiating transparent, ceiling prices for Low- and Middle-Income Countries (LMICs)
`3. Technical assistance to speed time-to-market for WHO-Prequalified and US FDA-
`approved products.
`4. Achieving regulatory approval for new combinations of drugs (eg, ritonavir/atazanavir;
`efavirenz/tenofovir/lamivudine, dolutegravir/lamivudine/tenofovir disoproxil fumarate).
`5. Novel technology to reduce the cost of Active Pharmaceutical Ingredients (APIs) for
`HIV/AIDS drugs, including: (a) efavirenz from $1100 to $95/kg; (b) tenofovir from $1100
`to $140/kg; (c) ritonavir from $3000 to $400/kg; and (d) lopinavir from $1900 to $450/kg.
`Laurus Labs adopted our chemistry for the synthesis of efavirenz to become the lowest-
`cost supplier of over 2,000 metric tons/year of this API.
`
` I
`
` presently work with organizations including the World Health Organization, the TB Alliance,
`UNITAID, USP, the Bill and Melinda Gates Foundation, and the Medicines Patent Pool on
`strategic market dynamics, novel chemistry and regulatory sciences for manufacturing, and
`regulation of medicines for LMICs. Our research team is a Technical Partner with
`USAID/USP for regulatory systems strengthening and harmonization for the “Journey to
`Self-Reliance” at part of USAID’s PQM+ Program ($160MM funding for 5 years).
`
`
` I
`
` assisted UNIDO (United Nations Industrial Development Organization) and the UN ANDI
`(African Network for Drugs and Diagnostics Innovation) organizations in implementing the
`Pharmaceutical Manufacturing Plan for Africa, outlining a strategy that was approved by
`the Heads of State of the 54 nations of the Organization of African States.
`
` I
`
` regularly teach a curriculum of courses in drug development, GMP and regulatory science
`at the University of Ibadan School of Pharmacy (Nigeria) and elsewhere in Africa (e.g., the
`St. Luke Foundation / Kilimanjaro School of Pharmacy in Moshi, TZ). Participants include
`National Drug Regulators, African pharmaceutical professionals, and University faculty. Our
`objectives are to assist National Drug Regulatory Agencies to achieve Strict Regulatory
`Authority status and to enable African companies to achieve WHO Prequalification. This
`effort was expanded into a MSc Degree program in 2014. Since 2008 we have had over 650
`people from 21 countries complete our training.
`
`3 
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` 
`
`DRL Ex. 1018, p. 003
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`

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`
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`Our work was awarded the American Chemical Society’s Astellas Foundation award for
`“Chemistry Impact on Human Health” in 2009. I was one of four scientists representing the
`United States at the Chemical Sciences and Society Summit in Beijing, in September 2011.
`I also delivered invited presentations at the WHO ANDI Stakeholders Meetings in Addis
`Ababa in October 2011 and January and November 2015. Our African partners have been
`designated as UN ANDI Centers of Excellence in Drug Manufacturing and Training, and
`Centers of Excellence in Regulatory Sciences. Our training course in reviewing generic
`drug submissions received a US FDA “Honor Award” for excellence and innovation in drug
`training and regulatory sciences. In 2013, I was a recipient of a Team Award from the
`African Union for Corporate Social Responsibility. In 2015, I was appointed to the Scientific
`Advisory Board for the Royal Society of Chemistry (UK) “Green Chemistry” division.
`
`Prior to my faculty appointment, I worked as a scientist and manager in the Innovator
`Pharmaceutical Industry (1983-2004). I contributed to over 100 New Chemical Entities
`(NCEs) that moved from Discovery into Development. Fourteen of these new NCEs were
`approved for marketing, including drugs for HIV/AIDS, cardiovascular disease, cancer, and
`several autoimmune diseases. In my most recent (2001-2004) industrial position I was the
`Head of Global Chemical Development I administered annual budgets of $150MM and
`managed approximately 500 scientists and technical experts. I am intimately familiar with
`the science and technology of Active Pharmaceutical Ingredient (API) and finished
`pharmaceutical product (FPP) drug production. I also have extensive, hands-on knowledge
`of drug patents, quality assurance, drug regulation, salt and polymorph screening and
`selection and physicochemical properties, clinical and marketing (IND and NDA)
`submissions, and Current Good Manufacturing Practice (cGMP).
`
`
`AWARDS AND APPOINTMENTS
`
`1. Technical Collaborator (PI) with the US Pharmacopeia’s PQM+ (Promoting the Quality of
`Medicines) funded by USAID at $169MM for 2019-2025.
`2. Collaborator (PI) with Management Sciences for Health MTaPS (Medicines,
`Technologies, and Pharmaceutical Services), program to help low- and middle-income
`countries implement a Global Health Security Agenda with USAID (2018-2013).
`3. Consultant to the WHO and the Government of Ethiopia in the National Strategic Plan
`for Local Pharmaceutical Manufacturing (2016-2018).
`
`4 
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` 
`
`DRL Ex. 1018, p. 004
`
`

`

` 
`
`4. Consultant to UNAIDS on the Strategic Market Dynamics of implementing Pre-exposure
`Prophylaxis (PrEP) for eliminating HIV/AIDS (2016-2019).
`5. Royal Society of Chemistry’s “Green Chemistry” Scientific Advisory Board (May 2015 –
`May 2019).
`6. Howard University Faculty Senate Award for contributions to Africa and the African
`Diaspora (May 2014).
`7. Appointment as an External Faculty member, University of Ibadan, (May 2014).
`8. African Medicines Regulatory Harmonization (AMRH) designated Center of Excellence
`in Regulatory training; St. Luke Foundation / Kilimanjaro School of Pharmacy Industrial
`Pharmacy Advanced Training (IPAT); Moshi, TZ (April 2014).
`9. WHUR radio interview with our research group on green chemistry and increasing global
`access to medicines, broadcast on February 13, 2014 available at:
`http://wamu.org/programs/metro_connection/13/02/14/this_week_on_metro_connection_
`chemistry_transcript
`10. United Nations Industrial Development Organization (UNIDO) Consultancy on training
`needs of the South African Pharmaceutical Industry (December 2013).
`11. African Union Commission Award for Social Responsibility, (September 2013).
`12. US FDA Honor Award (Team); Kilimanjaro School of Pharmacy IPAT for Excellence and
`Innovation in regulatory sciences, (September 2013).
`13. “Howard Prof. relies on green chemistry to improve drugs,” Interview with National Public
`Radio reporter Jonathan Wilson broadcast on February 15, 2013. Available on the
`Internet at WAMU Radio 88.5 “Metro Connection” at:
`http://wamu.org/programs/metro_connection/13/02/15/howard_prof_relies_on_green_ch
`emistry_to_improve_drugs
`14. Appointed member of the Strategic Advisory Group for funding priorities, UNITAID
`(2012-2013).
`15. Host of the American Chemical Society Webinars on “Green Chemistry” (2012-present;
`4-times yearly event).
`16. Posted on the American Chemical Society’s Nexus Blog: “Dr. Joseph Fortunak: Green
`Chemistry and Equal Access to Medicines,” by Christiana Briddell, December 7, 2012.
`Accessible at: https://communities.acs.org/community/science/sustainability/green-
`chemistry-nexus-blog/blog/2012/12/07/dr-joseph-fortunak-green-chemistry-and-equal-
`access-to-medicines
`17. United Nations ANDI (African Initiative for New Drugs and Diagnostics) designated
`Center of Excellence in drug manufacturing and training; St. Luke Foundation /
`Kilimanjaro School of Pharmacy IPAT (2012).
`18. Invited Presenter - American Chemical Society Webinar: “Chemistry, Human Rights, and
`Health,” April 18, 2012. Accessible at:
`http://www.acs.org/content/acs/en/global/international/science-and-human-
`rights/webinars.html.html
`19. Invited Presenter - American Chemical Society Webinar: “Green Chemistry and Global
`Access to Medicines,” presented June 14, 2012
`http://article.wn.com/view/2014/07/01/Taxing_the_Sick/
`
`5 
`
` 
`
`DRL Ex. 1018, p. 005
`
`

`

` 
`
`20. One of four external scientists selected to represent the United States at the “Chemical
`Sciences, Society, and Sustainability” (CS3) summit in Beijing, China (September,
`2011). The White Paper resulting from this meeting is available at:
`http://www.acs.org/content/acs/en/global/international/regional/eventsglobal/cs3.html .
`21. “Researchers manipulate drug’s chemistry in bid to lower treatment cost,” Wall Street
`Journal, May 13, 2011. This article described our new chemistry at Howard University
`to lower the costs of the HIV/AIDS drug tenofovir disoproxil fumarate:
`http://online.wsj.com/news/articles/SB1000142405274870373080457631948099082542
`2
`22. American Chemical Society “Astellas Foundation” Prize for Chemistry Impact on
`Human Health; ACS National Meeting, August 16, 2009.
`23. Appointed external Co-Director of the St. Luke Foundation / Kilimanjaro School of
`Pharmacy “Industrial Pharmacy Advanced Training” (IPAT) Program: August, 2008.
`24. Editorial Board, Tropical Journal of Pharmaceutical Research (2008-present)
`25. Appointed member of Nigerian National Institute of Pharmaceutical R&D (NIPRD);
`Expert Scientific Advisory Committee (ESAC; July, 2008).
`26. Appointed member of World Health Organization’s Stop TB Secretariat “Global Drug
`Facility” Business Advisory Committee (2006-2012).
`27. Editorial Board, Current Opinion in Drug Discovery and Development (2004-2009)
`Other Awards
` State of Illinois Governor’s Pollution Prevention Team Award (2004)
` Corporate Award from Abbott Labs for manufacturing improvements the reduced the
`rate of volatile organic emissions (VOEs) over the island of Puerto Rico by 60% (2004)
` Howard University Fund for Academic Excellence (2006)
` National Science Foundation (USA), Discovery Corps Senior Fellow (2006-2008)
` Collaboration with the African Union – a Business Plan for the Pharmaceutical
`Manufacturing Plan for Africa (2011-2012); approved by the Heads of State of the 54
`countries comprising the African Union
` Consultant; Medicines Patent Pool; (2012-present)
` Consultant; TB Alliance (2019-present)
` Partners for Supply Chain Management (SCMS) / USAID collaborative consulting; waste
`reduction and expired drug recycling in Africa, Latin America, and the Caribbean and
`member of the SCMS Quality Assurance Advisory Panel (2013-2019)
`
` 
`
`6 
`
`DRL Ex. 1018, p. 006
`
`

`

` 
`
`SERVICE AND CONSULTING
`
`Bill, Hillary, and Chelsea Clinton Foundation Healthcare Access Initiative (2005-2016)
`See above for a description of this work.
`
`St. Luke Foundation / Kilimanjaro School of Pharmacy IPAT (Industrial Pharmacy
`Training Unit); and University of Ibadan, School of Pharmacy (2007 - present)
`External Director of the IPAT, a Center of Excellence in Africa for drug manufacturing and
`training with the WHO ANDI (African Initiative for New Drugs and Diagnostics; 2012). The IPAT
`provides professional training for African Drug Regulators and pharmaceutical professionals to
`eliminate counterfeit and substandard medicines and enable African pharmaceutical companies
`to manufacture medicines meeting international standards of Quality-Assurance.
`
`Medicines sans Frontieres (MSF; Doctors Without Borders, and Medicines Patent Pool) –
`(2006; 2010; 2013-2014)
`Consultancy evaluating Brazilian pharmaceutical companies for production of HIV/AIDS drugs
`and APIs with quality-assurance. Transfer packages for the “Patent Pool” enabling the generic
`production of critical medicines for the treatment of HIV/AIDS, malaria, and tuberculosis.
`
`Brazilian Ministry of Health (September, 2010, January, 2014)
`One-week courses training the Brazilian pharmaceutical industry in the production of the
`HIV/AIDS drug efavirenz. One week of training in drug development and green chemistry for
`drug manufacturing.
`
`WHO “Stop TB” Campaign – Global Drug Facility, Business Advisory Council (BAC; 2006
`– 2012)
`Member of the Business Advisory Council, Global Drug Facility (GDF) of the WHO Stop TB
`Secretariat. The mission of the GDF is to provide effective medicines for the treatment of
`tuberculosis with assured quality.
`
`UNITAID Advisory Group on Funding Priorities (2012-2013)
`UNITAID is an organization with $400-500 million/year in funding whose strategic objective is to
`introduce new commodities into markets for developing nations that will 1) significantly improve
`global health; and 2) be sustainable for lasting impact. Examples of UNITAID initiatives include
`
` 
`
`7
`
`DRL Ex. 1018, p. 007
`
`

`

` 
`
`the introduction of generic pediatric medicines for HIV in Sub-Saharan Africa. My work with
`UNITAID includes co-authorship of the 2014 “Global HIV Medicines Landscape” and assisting
`UNITAID and the WHO in assuring the supply of quality-assured medications for clinical trials of
`HIV/AIDS and HCV treatments in children, women, and for patients with HIV-TB co-infection.
`
`National Academy of Sciences and American Chemical Society (NAS, ACS)
` NAS council on “Grand Challenges for Sustainability in the Chemical Industry” (2005)
` NAS “Green Chemistry Education Committee” (2005 – 2007)
` ACS “Strategic Redesigning the Petroleum Research Fund” (2007 - 2008)
` NAS “Committee on Chemical Substitution in Industry” (2008)
` Organizer, ACS Symposium on Process Chemistry in the Pharmaceutical and
`Agricultural Industries (2008)
` Session Chair, ACS Symposium on Green Chemistry and Chemical Manufacturing; ACS
`239th National Meeting, (August, 2009)
` Reviewer on Panel for funding of the ACS Teva Grants Panel (2009)
` Reviewer on Panel for REU Grants (2011, 2013)
` Reviewer on Panel for ACS GREET Awards (2012)
` Member of the ACS “Motivational Speakers Bureau” (2012)
` Host of the American Chemical Society’s “Green Chemistry” Webinar Series (2012-
`2014)
` Presenter (twice) of Chemistry for the improvement of global health and green chemistry
`for developing nations for the ACS’ Webinar series (2012, 2013)
` Organizer and Session Chair, “Industrial Applications of Green Chemistry,” Green
`Chemistry International meeting, Rockville, MD; June 18-20, 2014.
` Reviewer for the “Presidential Green Chemistry Awards” (American Chemical Society),
`2012 - 2018.
`
`Adjunct Professor
` University of Alabama, Green Chemistry Manufacturing Institute (2006 – 2014)
` St. Luke Foundation / Kilimanjaro School of Pharmacy, Industrial Pharmacy Advanced
`Training (2008 - present)
` University of Ibadan, School of Pharmacy (2014 - present)
`
`
` 
`
`8
`
`DRL Ex. 1018, p. 008
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`

`

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`
`Advisory Boards of Commercial Entities or NGOs
` LaGray Foundation for Drug Discovery and Development for Neglected Populations
`(Nsawam, Ghana)
`Initiative for Medicines Access and Knowledge (New York, NY and India; 2006 - 2018)
`
` Arvir Chemical manufacturing company (2007-2010), Republic of South Africa
` UNITAID Advisory Group on Funding Priorities (2011-2012)
` Scientific Advisory Committee, AviMed Pharma. AviMed is a biotechnology startup
`company involved in drug discovery for Schizophrenia and Alzheimer’s disease (2012)
` Scientific Advisory Board for the Public-Private Partnership “PlantSource” with the
`objective of bringing reliable medicines for malaria to the market at a cost of not more
`than $0.10 per treatment (2012)
` Scientific Advisory Board for “Cosmic Therapeutics”, India (2015-present)
`
`Nigeria, Zimbabwe, Tanzania and other African Countries (2005 - Present)
` Developed and delivered the first training course on GMP production of medicines in
`West Africa; Abuja, Nigeria, July 11 – 16, 2005.
` Collaborating with the National Institute of Pharmceutical R&D in Nigeria (NIPRD), NIH
`and USAID to construct a facility to prepare generic antimalarial drugs (2006 – 2008;
`2011-2012)
` Co-PI; grant from the USAID-UNCF Program to help re-build the University infrastructure
`for the AME University of Liberia (2007)
` Organized, arranged funding from the National Science Foundation (USA) and co-
`hosted an International Workshop on Green Chemistry and the Production of Essential
`Medicines, March 17-20, 2008
` Member, External Scientific Advisory Committee (ESAC) for NIPRD, (2008-2010)
` Member of the Organizing Committee, Conference on Green Chemistry and
`Conferences on Appropriate Technologies in Africa; Zimbabwe (2006), Rwanda (2008),
`South Africa (2007), and Ghana (2010)
` Co-PI on a MacArthur Foundation Award to the University of Ibadan, Nigeria for drug
`discovery, development and quality-assurance (2012-2015)
`
`Editorial Boards, Scientific Journals
`“Sustainability”, and “Sustainability: Chemistry”, 2016-present
`
`
`
`9
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`
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` 
`
`DRL Ex. 1018, p. 009
`
`

`

` 
`
`
`
`
`
`“Current Opinion in Drug Discovery and Development” 2006 – 2011
`“Journal of Tropical Pharmaceutical Research” 2008 – present
`“Green Chemistry Journal” – Royal Society of Chemistry 2015-2019
`
`RESEARCH ACTIVITIES
` New synthetic chemistry and methodology for the manufacture of essential medicines for
`the treatment of HIV/AIDS, malaria and tuberculosis
` New technologies for Green Chemistry, safety and waste reduction
` Teaching drug development and industrial pharmacy in Low- and Middle-Income
`Countries to enable local production according to international standards of Current
`Good Manufacturing Practice (cGMP)
`
`
`
`PREVIOUS WORK EXPERIENCE
`
`Head of Global Process R&D Division; Abbott Labs (2000 – 2004)
`Managed 225 - 450 employees, ~50% PhDs. Responsible for API and physicochemical pre-
`formulation activities for all new drug candidates; route discovery, polymorph control, clinical
`supplies, analytical & process development and validation for Abbott and external customers.
`Manufactured several small-volume, commercial products. Group consisted of:
` Analytical – Developed and validated test methods for intermediates, in-process
`controls, APIs and cleaning; specifications and Process Analytical Technologies (PATs)
` Pilot Plants - Operated three pilot plants and a potent drug facility for R&D, commercial,
`and third-party manufacturing under cGMP.
` Chemistry - Route discovery, development and clinical API supplies from first-in-man
`through process validation and commercial launch
` Engineering - Engineering development and technology transfer with special expertise in
`solid state, thermochemistry, kinetics, and hazards evaluation.
`
`
`
` 
`
`MAJOR ACCOMPLISHMENTS WITH ABBOTT LABS
` Created a Process Engineering Department with expertise in separations sciences,
`solids engineering and process modeling.
` Solid State Chemistry. Hired world-class scientists to decrease by 80% the API needed
`to develop a commercial formulation.
`
`10
`
`DRL Ex. 1018, p. 010
`
`

`

` 
`
` Validated processes for four New Drug Applications including the XIENCE™ V drug-
`device combination and the nucleotide anti-retroviral drug emtricitabine/Coviracil™
` Founded a Green Chemistry program that reduced waste by 45% in chemical pilot
`plants and reduced Volatile Organic Emissions over Puerto Rico by 65%
`
`MAJOR ACCOMPLISHMENTS WITH DuPONT PHARMA (1993 – 2000)
` Led the CMC (Chemistry, Manufacturing, Controls) development team for Losoxantrone
`(breast cancer) including Regulatory, marketing application and pre-approval
`inspections.
` Led the API development team for the HIV drug Efavirenz, an inhibitor of HIV-1 reverse-
`transcriptase; providing API for the treatment of 77,000 people on expanded access
`during development. Efavirenz was approved by the US FDA within 13 months of first
`dosing in humans, a record time for a
`
`
`
`
`
`MAJOR ACCOMPLISHMENTS WITH SMITHKLINE BEECHAM CO. (1983 – 1993)
`Invented commercial API processes for the FDA-approved drugs Halofantrine,
`Ropinerole, Topotecan, and Eprosartan.
`
`
`SUMMARY OF PREVIOUS EXPERIENCE
`I have been responsible for creating and implementing the vision of chemical and
`pharmaceutical drug development in Pharmaceutical R&D. I have invented new chemical
`reactions and processes, and have an extensive record of publications, patents, and
`presentations. I am experienced in dealing with commercial and contract manufacturers, the US
`FDA and other Regulatory agencies. I worked on the industry initiatives PQRI, BACPAC I & II,
`GMPs for the 21st Century, and the PhRMA Technical Group. Production processes for
`commercially approved new drugs that I significantly contributed to include:
`
`Drug
`Halofantrine
`Ropinerole
`
`Topotecan
`
`
`
`
`
`11
`
`Proprietary Name (™)
`Halfan
`
`
`Requip
`
`
`
`
`
`
` Hycamptin
`
`
`
`
`
`
`Eprosar
`
`
`
`Indication
`Malaria
`Parkinson's Disease,
`Restless-leg syndrome
`Ovarian, Breast and Small-
`Cell Lung cancer
`Hypertension; Heart Failure
`
`Eprosartan
`
` 
`
`DRL Ex. 1018, p. 011
`
`

`

` 
`
`Breast cancer
`
`
`
`
`Losoxantrone
`HIV/AIDS
`
`
`Sustiva
`Efavirenz
`Breast, Ovarian cancer and
`
`
`(NaPro
`Paclitaxcel
`Karposi’s sarcoma
`
`BioTherapeutics)
`
`HIV/AIDS
`
`Coviracil
`
`Emtricitabine
`HIV/AIDS
`
`Kaletra (heat stable) Lopinavir/Ritonavir
`
`Drug/Device combination for
`
`XIENCE™ V
`Everolimus
`
`restenosis after coronary angioplasty
`
`
`
`
`HIV/AIDS
`
`Tenofovir Disoproxil Viread
`
`Fumarate (TDF)
`(With generic companies operating under license from the innovator
`company, Gilead Sciences)
`Trilipix™
`
`
`Febuxostat™
`
`
`Cholesterol management
`Gout
`
`Fenofibric Acid
`Uloric
`
` I
`
` have also managed or participated in the regulatory submission and marketing approval of 25+
`new generic products.
`
`
`OTHER EXTERNAL ACCOMPLISHMENTS
` Scientific Advisory Board - NaPro Biotherapeutics, Boulder, CO, 1993-1999 Commercial
`semi-synthesis of paclitaxcel from renewable biomass.
` Speaker - US FDA internal sessions to train inspectors on Marketing Applications and Pre-
`Approval Inspections (1997-2000)
` Chair - Regulatory and Compliance Section for the Midwest Pharmaceutical Process
`Chemistry Consortium (2001 – 2004)
`
`
`
`
`PUBLICATIONS (THROUGH 2017)
`1. Trost, B.M., Verhoeven, T., and Fortunak, J.M., “Isomerization of Allylic Acetates Catalyzed
`by Palladium. New Method for Stereocontrol” Tetrahedron Letters, 2301, 1979.
`2. 2. Trost, B.M. and Fortunak, J.M. "A New Diene Synthesis via Organopalladium Chemistry”
`J. Am. Chem. Soc., 102, 2841, 1980.
`3. Trost, B.M. and Fortunak, J.M., "Palladium-Catalyzed Fragmentation Reaction as an
`Approach to Vitamin A Ester" Tetrahedron Letters, 22, 3459, 1981.
`4. Trost, B.M. and Fortunak, J.M. "Cyclizations Initiated by a Pd2+-Ag+ Mixed-Metal System"
`Organometallics, 1, 7, 1982.
`
` 
`
`12
`
`DRL Ex. 1018, p. 012
`
`

`

` 
`
`5. Fleming, I., Murahashi, S.-I., Naota, T., Tanigawa, Y. and Fortunak, J., “Palladium-
`Phosphine Complex Catalyzed Reaction of Organolithium Compounds and Alkenyl Halides:
`(Z)-β-[2-(N,N-dimethylamino)phenyl]styrene” Organic Syntheses, Vol. 62, 1984, p. 39.
`6. Fleming, I., Fortunak, J.M., et al., “An Approach to the Synthesis of Gelsemine” New Trends
`in Natural Products Chemistry, Atta-ur-Rahman, LeQuesne, Eds.; Elsevier: Amsterdam,
`1986, p. 83.
`7. McMurry, J.E., Musser, J.H., Fleming, I., Fortunak, J. and Nubling, C., “Preparation of β-nitro
`acrylic ester” Organic Syntheses, Coll. Vol. 6, 1988, p. 799.
`8. 8. Fleming, I., Fortunak, J.M. et al., "An Approach to the Synthesis of Gelsemine"
`Tetrahedron, 44, 3931-3944, 1988.
`9. Fortunak, J.M., Mellinger, M. and Wood, J. "A Convenient Preparation of Mappicine Ketones
`from Camptothecins: Chemistry of the Camptothecin E-Ring" Tetrahedron Letters, 35, 5763,
`1994.
`10. Fortunak J.M., Walsgrove, T.C., Giles, R.G., et al. "Some Synthetic Approaches to
`Ropinerole (SK&F 101468-A): A Potent Dopamine Receptor Antagonist" J. Het. Chem. 32,
`875, 1995.
`11. Wood, J.L., Fortunak, J.M., Mastrocola, A.R., Mellinger, M., and Burk, P.L. “An Efficient
`Conversion of Camptothecin to 10-Hydroxycamptothecin.” J. Org. Chem., 60, 5739, 1995.
`12. Pierce, M.E., Islam, Q. and Fortunak, J.M. "A Practical Photochemical Synthesis of 6-Aza-
`1,10-Phenanthroic Anhydride" Synth. Commun. 26, 3645, 1996.
`13. Fortunak, J.M.D., Mastrocola, A.R., Mellinger, M., Sisti, N.J., Wood, J.L., and Zhuang, Z.-P.
`"Novel Syntheses of Camptothecin Alkaloids, Part 1. Intramolecular [4+2] Cycloadditions of
`N-Arylimidates and 4H-3,1-Benzoxazin-4-ones as 2-Aza-1,3-Dienes" Tetrahedron Letters,
`37, 5679, 1996.
`14. Fortunak, J.M.D., Kitteringham, J., Mastrocola, A.R., Mellinger, M., Sisti, N.J., Wood, J.L.
`and Zhuang, Z.-P. "Novel Syntheses of Camptothecin Alkaloids, Part 2. Concise Synthesis
`of (S)-Camptothecins" Tetrahedron Letters, 37, 5683, 1996.
`15. Shilcrat, S.C., Mokhallalati, M.K., Fortunak, J.M.D. and Pridgen, L.N. "A New,
`Regioselective Synthesis of 1,2,5-Trisubstituted 1H-Imidazoles and Its Application to the
`Development of Eprosartan" J. Org. Chem., 62, 8449, 1997.
`16. Wang, Z., La, B., and Fortunak, J.M. "Enantioselective Synthesis of α-Hydroxy Carboxylic
`Acids: Direct Conversion of α-Oxocarboxylic Acids to Enantiomerically Enriched α-Hydroxy
`Carboxylic Acids via Neighboring Group Control" Tetrahedron Letters, 39, 5501, 1998.
`17. Williams, R.C., Riley, C.M., Sigvardson, K.W., Fortunak, J., Ma, P., Nicolas, E.C., Unger,
`S.E., Krahn, D.F. and Brenner, S.L. "Pharmaceutical Development and Specification of
`Stereoisomers" J. Pharm. Biomed. Anal., 17, 917, 1998.
`18. Pierce, M.E., Parsons, R.L., Radesca, L.A., Fortunak, J.M.D., et al. "Practical Asymmetric
`Synthesis of Efavirenz (DMP-266) an HIV-1 Reverse Transcriptase Inhibitor" J. Org. Chem.,
`63, 8536, 1998.
`19. Wang, Z., Zhao, C., Pierce, M.E. and Fortunak, J.M. “Enantioselective Synthesis of β-
`Hydroxy Carboxylic Acids...” Tetrahedron Asymmetry, 10, 225, 1999.
`20. Wang, Z., Yin, J.G., Campagna, S., Pesti, J.A. and Fortunak, J.M. “An Alternative Approach
`for the Conversion of Aldehydes to Terminal Alkynes” J. Org. Chem., 64, 6918, 1999.
`
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`21. Kauffman, G.S., Harris, G.D., Dorow, R.L., Stone, B.R.P., Parsons, R.L., Pesti, J.A.,
`Magnus, N.A., Fortunak, J.M., Confalone, P.N. and Nugent, W.A. “An Efficient Chiral
`Moderator Prepared from Inexpensive (+)-3-Carene: Synthesis of ...DPC 963” Organic
`Letters, 2, 3119, 2000.
`22. Wang, Z., Campagna, S., Xu, G., Pierce, M.E., Fortunak, J.M. and Confalone, P.N. “A New
`and Practical Synthesis of Vinyl Dichlorides via a non-Wittig-Type Approach” Tetrahedron
`Letters, 41, 4007, 2000.
`23. Wang, Z., Fortunak, J.M. et al. "A Practical Preparation of Terminal Alkynes From
`Aldehydes" J. Org. Chem., 65, 1889, 2000.
`24. Fortunak, J.M., Pesti, J.A., Earl, R.A. et al., “Efficient Pyridinylmethyl Functionalization:
`Synthesis of 10,10-Bis[(2-fluoro-4-pyridinyl)methyl]-9(10H)-anthracenone (DMP 543), an
`Acetylcholine Release Enhancing Agent” J. Org. Chem., 65, 7718-7722, 2000.
`25. Parsons, R.L., Fortunak, J.M., Collum, D.B., et al. "NMR Spectroscopic Investigations of
`Mixed Aggregates Underlying Highly Enantioselective 1,2-Additions of Lithium
`Cyclopropylacetylide to Quinazolinones" J. Am. Chem. Soc. 123, 9135, 2001.
`26. Sigvardson, K.W., Adams, S.P., Barnes, T.B., Blom, K.F., Fortunak, J.M., Haas, M.J., Reilly,
`K.L., Repta, A.J. and Nemeth, G.A. “The Isolation and Identification of a Toxic Impurity in
`XP315 Drug Substance” J. Pharm. Biomed. Anal., 27(1-2), 327, 2002.
`27. Fortunak, J.M., Storace, L., Confalone, P.N. et al., “An Efficient Large-Scale Process for the
`Human Leukocyte Elastase Inhibitor, DMP 777” J. Org. Proc. Res. Dev., 6(1), 54, 2002.
`28. Choudhury, A., Moore, J.R., Pierce, M.E., Fortunak, J.M., Valvis, I.I. and Confalone, P.N. “In
`situ Recycling of Chiral Ligand and Surplus Nucleophile for a non-Catalytic Reaction:
`Amplification of Process Throughput in the Asymmetric Addition Step of Efavirenz (DMP
`266)” J.Org. Proc. Res. Dev., 7(3), 324, 2003.
`29. Pesti, J.A., Yin, J., Fortunak, J., et al., “Efficient Preparation of a Key Intermediate in the
`Synthesis of Roxifiban by Enzymatic Dynamic Kinetic Resolution” J. Org. Proc. Res. Dev.,
`8(1), 22, 2004.
`30. Briggs, T.F., Collum, D.B., Fortunak, J.M., et al., “Structural and Rate Studies of the 1,2-
`Additions of Lithium Phenylacetylide to Lithiated Quinazolinones: Influence of Mixed
`Aggregates on the Reaction Mechanism.” J, Am, Chem. Soc., 126, 5427, 2004.
`31. Yue, T.-Y., McLeod, D.D., Albertson,, K.R., Beck, S.R., Deerberg, J., Fortunak, J.M.,
`Nugent, W.A., Radesca, L.A., Tang, L., and Xiang, C.D. “Stereoselective Process for a
`CCR3 Antagonist” J. Org. Proc. Res. Dev., 226, 2006
`32. Yue, T.-Y., McLeod, D.D., Albertson,, K.R., Beck, S.R., Deerberg, J., Fortunak, J.M.,
`Nugent, W.A., Radesca, L.A., Tang, L., and Xiang, C., “Synthesis of a CCR3 Antagonist”
`Synfacts, 2006(9):0863, 2006.
`33. Fortunak, J.M.D.;* King, C.L.; Silverton, T.; Ohwoavworhua, F.; Swatloski, R.; and Kunle,
`O.O. “Valuable Products Derived from Nigerian Grasses.” In: Proceedings from the 2nd
`International Conference on Appropriate Technology. National University of Science and
`Technology (NUST), Zimbabwe, July 12 – 15, 2006.
`34. Fortunak J, Confalone PN, Grosso JA “Strength and Honor through the Pharmaceutical
`Industry’s Embrace of Green Chemistry?” Current Opinion in Drug Discovery and
`Development, 10(6), 651-653 2007.
`
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`35. Pinheiro, E.D-S.; Antunes, O.A.C.; Fortunak, J.M.D. “A Survey of the syntheses of active
`pharmaceutical ingredients for anti